GEN News Highlights

AdvanDx received FDA 510(k) clearance for a 90-minute protocol for its Enterococcus faecalis/OE PNA FISH® test. Enterococcus species cause bloodstream infections (BSI). While infections with E. faecalis are generally susceptible to ampicillin and rarely resistant to vancomycin, infections with E. faecium and other enterococci (OE) are frequently resistant to both drugs. Since conventional identification methods can take three days or longer, the company points out, up to 80% of vancomycin-resistant enterococci receive inappropriate antibiotic therapy.

AdvanDx reports that its new protocol reduces the PNA FISH turnaround time from two and half hours to 90 minutes by decreasing PNA probe hybridization from 90 minutes to 30 minutes. Clinical validation studies performed at hospitals in the U.S. and Europe demonstrated 100% equivalence between the 90-minute protocol and the original PNA FISH protocol, the company adds. E. faecalis/OE PNA FISH® is distributed by bioMerieux in the U.S.

“The faster protocol marks another milestone toward AdvanDx’ goal of providing a fast, easy-to-use, and broad molecular diagnostic platform for early identification of bloodstream pathogens,” remarks Thais T. Johansen, president and CEO. “With results in 90 minutes, hospitals will be able to provide critical results as early as possible, enabling clinicians to improve care and outcomes for patients with life-threatening infections.”

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.

Be sure to take the GEN Poll

Climate Change

How would you describe the researchers response to the 2°C global temperature target?

They are right on the mark. A 2°C global temperature rise will push us further over the edge. We have to set a lower target.

A 2°C global temperature rise is a reasonable target on which to focus in order to diminish the impact of climate change.

We have already gone beyond the threshold for getting a handle on climate change. So now we just need to learn how to adapt to the inexorable climatic changes with which we will have to deal going forward.

They are right on the mark. A 2°C global temperature rise will push us further over the edge. We have to set a lower target.

38.9%

A 2°C global temperature rise is a reasonable target on which to focus in order to diminish the impact of climate change.

22.2%

We have already gone beyond the threshold for getting a handle on climate change. So now we just need to learn how to adapt to the inexorable climatic changes with which we will have to deal going forward.

If you have any questions about your subscription, click
hereto email us or call at (914) 740-2189.

You may also be interested in subscribing to the GEN magazine, an indispensable
resource for everyone involved in the business of translating discoveries at the
bench into solutions that fight disease and improve health, agriculture, and the
environment. Subscribe
today to see why over 60,000 biotech professionals read GEN to
keep current in the areas of genomics, proteomics, drug discovery, biomarker discovery,
bioprocessing, molecular diagnostics, collaborations, biotech business trends, and
more.